Epinastine hydrochloride

Epinastine hydrochloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Epinastine hydrochloride is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Epinastine hydrochloride ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.

Dosage

• The recommended dosage is one drop in each eye twice a day.

• Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

DOSAGE FORMS AND STRENGTHS

• Solution containing 0.5 mg/mL epinastine hydrochloride

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Epinastine hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Epinastine hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Epinastine hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Epinastine hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Epinastine hydrochloride in pediatric patients.

Contraindications

• None

Warnings

Contamination of Tip and Solution

• Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

• Bottle should be kept tightly closed when not in use.

Use with Contact Lenses

• Patients should be advised not to wear a contact lens if their eye is red. Epinastine hydrochloride ophthalmic solution should not be used to treat contact lens-related irritation.

• The preservative in epinastine hydrochloride, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of epinastine hydrochloride ophthalmic solution and may be reinserted after 10 minutes following its administration.

Topical Ophthalmic Use Only

• Epinastine hydrochloride is for topical ophthalmic use only and not for injection or oral use.

Adverse Reactions

Clinical Trials Experience

• Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

• The most frequently reported ocular adverse reactions occurring in approximately 1 to 10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus.

• The most frequently reported non-ocular adverse reactions were infection (cold symptoms and upper respiratory infections), seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis, seen in approximately 1 to 3% of patients.

• Some of these reactions were similar to the underlying disease being studied.

Postmarketing Experience

• The following reactions have been identified during postmarketing use of epinastine hydrochloride in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to epinastine hydrochloride, or a combination of these factors, include: lacrimation increased.

Drug Interactions

There is limited information regarding Epinastine hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Teratogenic Effects

Pregnancy Category C

• In an embryofetal developmental study in pregnant rats, maternal toxicity with no embryofetal effects was observed at an oral dose that was approximately 150,000 times the maximum recommended ocular human dose (MROHD) of 0.0014 mg/kg/day on a mg/kg basis. Total resorptions and abortion were observed in an embryofetal study in pregnant rabbits at an oral dose that was approximately 55,000 times the MROHD. In both studies, no drug-induced teratogenic effects were noted.

• Epinastine reduced pup body weight gain following an oral dose to pregnant rats that was approximately 90,000 times the MROHD.

• There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, epinastine hydrochloride ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Epinastine hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Epinastine hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Epinastine hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Epinastine hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Epinastine hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Epinastine hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Epinastine hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Epinastine hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Epinastine hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Epinastine hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Epinastine hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Epinastine hydrochloride in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Epinastine hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Epinastine hydrochloride in the drug label.

Pharmacology

There is limited information regarding Epinastine hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Epinastine hydrochloride01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Epinastine hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Epinastine hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Epinastine hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Epinastine hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Epinastine hydrochloride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Epinastine hydrochloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Epinastine hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Epinastine hydrochloride in the drug label.

Precautions with Alcohol

• Alcohol-Epinastine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Page Name=Epinastine hydrochloride
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Epinastine hydrochloride
 |Label Name=Epinastine hydrochloride11.png

}}

{{#subobject:

 |Label Page=Epinastine hydrochloride
 |Label Name=Epinastine hydrochloride11.png

}}